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LEVETIRACETAM TEVA 100 MG/ML ORAL SOLUTION

Active substance(s): LEVETIRACETAM

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TEVA UK Ref:

Dimensions Changed:
No
Length:
420 mm
Width:
154 mm
Depth:
N/A
Foil Width:
N/A

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Read all of this leaflet carefully before you or your
child start taking this medicine because it contains
important information for you.
‐ Keep this leaflet. You may need to read it again.
‐ If you have any further questions, ask your doctor
or pharmacist.
‐ This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even
if their signs of illness are the same as yours.
‐ If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:

1 What Levetiracetam Teva 100 mg/ml oral solution
is and what it is used for
2 What you need to know before you take
Levetiracetam Teva 100 mg/ml oral solution
3 How to take Levetiracetam Teva 100 mg/ml oral
solution
4 Possible side effects
5 How to store Levetiracetam Teva 100mg/ml oral
solution
6 Contents of the pack and other information

What Levetiracetam Teva 100 mg/ml
Oral Solution is and what it is used for

Levetiracetam Teva 100 mg/ml oral solution is an
antiepileptic medicine (a medicine used to treat
seizures in epilepsy).
Levetiracetam Teva is used:
• on its own in adults and adolescents from 16
years of age with newly diagnosed epilepsy, to
treat a certain form of epilepsy. Epilepsy is a
condition where the patients have repeated fits
(seizures). Levetiracetam is used for the epilepsy
form in which the fits initially affect only one side
of the brain, but could thereafter extend to larger
areas on both sides of the brain (partial onset
seizure with or without secondary
generalisation). Levetiracetam has been given to
you by your doctor to reduce the number of fits.
• as an add-on to other antiepileptic medicines to
treat:
- partial onset seizures with or without
generalisation in adults, adolescents, children
and infants from one month of age
- myoclonic seizures (short, shock-like jerks of a
muscle or group of muscles) in adults and
adolescents from 12 years of age with juvenile
myoclonic epilepsy
‐ primary generalised tonic-clonic seizures
(major fits, including loss of consciousness) in
adults and adolescents from 12 years of age
with idiopathic generalised epilepsy (the type
of epilepsy that is thought to have a genetic
cause).

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16 June 2016

Colours Used:

Levetiracetam Teva 100 mg/ml
Oral Solution

1

Version:

231-30-64216-D LEA LEVETIRACETAM 100mg/ml SOL TUK
BLACK
PANTONE® GREEN C
Template

parahydroxybenzoate (E216) which may cause
allergic reactions (possibly delayed).
Levetiracetam Teva oral solution also contains
maltitol. If you have been told by your doctor that
you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.

3

How to take Levetiracetam Teva 100
mg/ml Oral Solution

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Take the oral solution following your doctor’s
instructions.
Levetiracetam Teva must be taken twice a day,
once in the morning and once in the evening, at
about the same time each day.
Monotherapy
Dose in adults and adolescents (From 16 years of age):
General dose: between 10 ml (1,000 mg) and 30 ml
(3,000 mg) each day, divided in 2 intakes per day.
When you first start taking Levetiracetam Teva,
your doctor will prescribe you a lower dose for
2 weeks before giving you the lowest general dose.
Add-on therapy
Dose in adults and adolescents aged 12 to 17 years
weighing 50 kg or more:
General dose: between 10 ml (1,000 mg) and 30 ml
(3,000 mg) each day, divided in 2 intakes per day.
Dose in infants aged 1 month to 23 months, children
aged 2 to 11 years and adolescents aged 12 to 17
years, weighing less than 50 kg:
Your doctor will prescribe the most appropriate
pharmaceutical form of Levetiracetam according to
the age, weight and dose.
Oral solution is a formulation more appropriate to
infants and children under the age of 6 years and to
children and adolescent (from 6 to 17 years)
weighing less than 50kg and when tablets don’t
allow accurate dosage.
General dose: between 0.2 ml (20 mg) and 0.6 ml
(60 mg) per kg bodyweight each day, divided in
2 intakes per day. The exact quantity of oral solution
formulation should be measured using the syringe
(provided in the cardboard box) and then emptying
the contents of the syringe into either a glass of
water or baby’s bottle.
Weight

Starting dose:
0.1 ml/kg
twice daily

Maximum dose:
0.3 ml/kg
twice daily

6 kg
8 kg

0.6 ml twice daily
0.8 ml twice daily

1.8 ml twice daily
2.4 ml twice daily

10 kg
15 kg
20 kg

1 ml twice daily
1.5 ml twice daily
2 ml twice daily

3 ml twice daily
4.5 ml twice daily
6 ml twice daily

25 kg

2.5 ml twice daily

7.5 ml twice daily

From 50 kg 5 ml twice daily

15 ml twice daily

What you need to know before you take
Children 25 kg or less should start the treatment
Levetiracetam Teva 100 mg/ml Oral
with Levetiracetam Teva 100 mg/ml oral solution
Solution

Do not take Levetiracetam Teva
If you are allergic to levetiracetam, pyrrolidone
derivatives or any of the other ingredients of this
medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking this
medicine:
• if you suffer from kidney problems, follow your
doctor’s instructions. He/she may decide if your
dose should be adjusted.
• if you notice any slow down in the growth or
unexpected puberty development of your child,
please contact your doctor.
• a small number of people being treated with
anti-epileptics such as Levetiracetam Teva have
had thoughts of harming or killing themselves. If
you have any symptoms of depression and/or
suicidal ideation, please contact your doctor.
Children and adolescents
• Levetriacetam Teva is not indicated in children
and adolescents below 16 years on its own
(monotherapy).
Other medicines and Levetiracetam Teva
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Do not take macrogol (a drug used as laxative) for
one hour before and one hour after taking
levetiracetam as this may result in a loss of its effect.
Pregnancy and breast-feeding
If you are pregnant or breastfeeding, think you may
be pregnant or are planning to have a baby, ask
your doctor for advice before taking this medicine.
Levetiracetam Teva should not be used during
pregnancy unless clearly necessary. A risk of birth
defects for your unborn child cannot be completely
excluded. Levetiracetam Teva has shown unwanted
reproductive effects in animal studies at dose levels
higher than you would need to control your seizures.
Breast-feeding is not recommended during treatment
Driving and using machines
Levetiracetam Teva may impair your ability to drive
or operate any tools or machinery, as it may make
you feel sleepy. This is more likely at the beginning
of treatment or after an increase in the dose. You
should not drive or use machines until it is
established that your ability to perform such
activities is not affected.
Levetiracetam Teva 100 mg/ml oral solution
contains methyl parahydroxybenzoate, propyl
parahydroxybenzoate and maltitol
Levetiracetam Teva oral solution includes methyl
parahydroxybenzoate (E218) and propyl

Dose in children and adolescents 50 kg or more is
the same as in adults
Dose in infants aged 1 month to less than 6 months:
General dose: between 0.14 ml (14 mg) and 0.42 ml
(42 mg) per kg bodyweight each day, divided in
2 intakes per day. The exact quantity of oral solution
formulation should be measured using the syringe
provided in the cardboard box and then emptying
the contents of the syringe into either a glass of
water or baby’s bottle.
Weight Starting dose:
0.07 ml/kg twice
daily

Maximum dose:
0.21 ml/kg twice
daily

4 kg
5 kg

0.3 ml twice daily
0.35 ml twice daily

0.85 ml twice daily
1.05 ml twice daily

6 kg
7 kg

0.45 ml twice daily
0.5 ml twice daily

1.25 ml twice daily
1.5 ml twice daily

Method of administration:
Levetiracetam Teva oral solution
may be diluted in a glass of
1 water or baby´s bottle. You may
take Levetiracetam with or
without food.
Instructions for use:
• Open the bottle: press the cap
and turn it anticlockwise
(figure 1).

2

• Insert the syringe adaptor
into the bottle neck (figure 2).
Ensure it is well fixed.

3

• Take the syringe and put it in
the adaptor opening (figure 2).
• Turn the bottle upside down
(figure 3).

4

5

• Fill the syringe with a small
amount of solution by pulling
the piston down (figure 4),
then push the piston upward
in order to remove any
possible bubbles (figure 5).
Pull the piston down to the
graduation mark
corresponding to the quantity
in millilitres (ml) prescribed by
your doctor (figure 6).

TEVA UK Ref:

231-30-64216-D LEA LEVETIRACETAM 100mg/ml SOL TUK Dimensions Changed:
No
Length:
420 mm
Width:
154 mm
Depth:
N/A
Foil Width:
N/A

Colours Used:

Version:

2

16 June 2016

BLACK
PANTONE® GREEN C
Template

• Turn the bottle the right way up. • elevated/abnormal values in a liver function test
• hair loss, eczema, pruritus
• muscle weakness, myalgia (muscle pain)
• injury.
Rare: may affect 1 to 10 users in 10,000 people
• Empty the contents of the
• infection
syringe
into
a
glass
of
water
6 or baby’s bottle by pushing
• decreased number of all blood cell types
• severe allergic reactions (DRESS, anaphylactic
the piston to the bottom
reaction [severe and important allergic reaction],
(figure 7).
Quincke’s oedema [swelling of the face, lips,
tongue and throat]);
• Drink the whole contents of
• suicide, personality disorders (behavioural
the glass / baby´s bottle
problems), thinking abnormal (slow thinking,
7 • Close the bottle with the plastic unable to concentrate)
• uncontrollable muscle spasms affecting the
screw cap.
head, torso and limbs, difficulty in controlling
• Wash the syringe with water
movements, hyperkinesia (hyperactivity)
only (figure 8).
• liver failure ,hepatitis
• Low blood levels of sodium which can cause
tiredness and confusion, muscle twitching, fits or
8
coma.
Reporting
of side effects
Duration of treatment:
Levetiracetam Teva is used as a chronic treatment. If you get any side effects, talk to your doctor or
You should continue Levetiracetam Teva treatment pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
for as long as your doctor has told you.
effects directly via the Yellow Card Scheme at:
Do not stop your treatment without your doctor’s
www.mhra.gov.uk/yellowcard.
advice as this could increase your seizures.
By reporting side effects you can help provide more
If you take more Levetiracetam Teva than you
information on the safety of this medicine.
should:
The possible side effects of an overdose of
5 How to store Levetiracetam Teva
Levetiracetam Teva are sleepiness, agitation,
100mg/ml Oral Solution
aggression, decrease of alertness, inhibition of
Keep out of the sight and reach of children.
breathing and coma.
Contact your doctor if you took more Levetiracetam Do not use this medicine after the expiry date
Teva than you should. Your doctor will establish the stated on the cardboard box and bottle after EXP.
The expiry date refers to the last day of the month.
best possible treatment for an overdose.
Do not use after 7 months of first opening the bottle.
If you forget to take Levetiracetam Teva:
Contact your doctor if you have missed one or more Due to sensitivity to light, store in the original
container.
doses.
Do not take a double dose to make up for a
Store in an upright position.
forgotten dose.
Do not thorw away any medicines via wastewater
If you stop taking Levetiracetam Teva:
or household waste. Ask your pharmacist how to
Do not stop your treatment without your doctor’s
throw away medicines you no longer use. These
advice as this could increase your seizures.
measures will help to protect the environment.
If stopping treatment, Levetiracetam Teva should be
of the pack and other
discontinued gradually to avoid an increase of
6 Contents
seizures.
information
Should your doctor decide to stop your Levetiracetam
What
Levetiracetam
Teva 100 mg/ml oral solution
Teva treatment, he/she will instruct you about the
contains
gradual withdrawal of Levetiracetam Teva.
The active substance is levetiracetam. Each ml
If you have any further questions on the use of this contains 100 mg of levetiracetam.
medicine, ask your doctor or pharmacist.
The other ingredients are:
Sodium citrate
4 Possible side effects
Citric acid monohydrate
Like all medicines, this medicine can cause side
Methyl parahydroxybenzoate (E218)
effects, although not everybody gets them.
Propyl parahydroxybenzoate (E216)
Ammonium glycyrrhizate
You should go to Accident and Emergency
Glycerol (E422)
immediately if you experience symptoms of;
Maltitol liquid (E965)
• serious allergic reaction that may begin with a
skin rash, which may form blisters and looks like Acesulfame potassium (E950)
small targets (central dark spots surrounded by a Grapefruit flavour
Purified water
paler area, with a dark ring around the edge)
(erythema multiforme)
What Levetiracetam Teva 100 mg/ml oral solution
• a widespread rash with blisters and peeling skin, looks like and contents of the pack
particularly around the mouth, nose, eyes and
Levetiracetam Teva 100 mg/ml oral solution is a
genitals (Stevens-Johnson syndrome)
• a more severe form causing skin peeling in more clear liquid.
50 ml solution (sample pack) in an amber glass
than 30% of the body surface (toxic epidermal
bottle with a white child resistant closure in a
necrolysis)
• a rash, fever, inflammation of internal organ and cardboard box also containing a 1 ml oral syringe
(graduated every 0.05 ml) and an adaptor for the
blood abnormalities including an increase in
syringe.
white blood cells (DRESS syndrome).
You should contact your doctor immediately if you 150 ml solution in an amber glass bottle with a white
child resistant closure (for infants aged 1 month to
experience symptoms of severe abdominal and
less than 6 months) in a cardboard box also
back pain accompanied with feeling very unwell
containing a 1 ml oral syringe (graduated every
(pancreatitis) or hepatic failure.
0.05 ml) and an adaptor for the syringe.
You should see your doctor immediately if you
experience depression, emotional instability/mood 150 ml solution in an amber glass bottle with a white
child resistant closure (for infants and young
swings, or suicidal thoughts or behaviour.
children aged from 6 months to less than 4 years) in
You should also seek medical attention if you
experience a hypersensitivity reaction (for example a cardboard box also containing a 3 ml oral syringe
(graduated every 0.1 ml) and an adaptor for the
itching, rash, hives, difficulty breathing).
syringe.
Some of the side effects like sleepiness, tiredness
300 ml solution in an amber glass bottle with a white
and dizziness may be more common at the
child resistant closure (for children aged 4 years
beginning of the treatment or at dose increase.
These effects should however decrease over time. and above, adolescents and adults) in a cardboard
box also containing a 10 ml oral syringe (graduated
Very common: may affect more than 1 in 10 people every 0.25 ml) and an adaptor for the syringe.
• nasopharyngitis (cough, sore throat, runny nose
Not all pack sizes may be marketed.
and fever)
Marketing Authorisation Holder and Manufacturer
• somnolence (sleepiness); headache.
Common: may affect up to 1 to 10 users in 100 people Marketing Authorisation Holder
• anorexia (loss of appetite)
Teva UK Limited
• hostility or aggression, anxiety, insomnia,
Eastbourne
nervousness or irritability
BN22 9AG
• convulsion, balance disorder (equilibrium
United Kingdom
disorder), dizziness (sensation of unsteadiness),
lethargy (lack of energy and enthusiasm), tremor Manufacturer
Bluepharma Indústria Farmacêutica, S.A.
(involuntary trembling)
S. Martinho de Bispo
• vertigo (sensation of rotation)
3045-016 Coimbra
• cough
Portugal
• abdominal pain, diarrhoea, dyspepsia
This leaflet was last revised in 06/2016
(indigestion), vomiting, nausea
• rash
PL 00289/1703
• asthenia/fatigue (tiredness).
Uncommon: may affect 1 to 10 users in 1000 people
• decreased number of blood platelets, decreased
number of white blood cells
• weight decrease, weight increase
• suicide attempt, mental disorder, abnormal
behaviour, hallucination, anger, confusion, panic
attack, agitation
• amnesia (loss of memory), memory impairment
(forgetfulness), abnormal coordination/ataxia
(impaired coordinated movements), paraesthesia
(tingling), disturbance in attention (loss of
concentration)
64216-D
• diplopia (double vision), vision blurred
• Remove the syringe from the
adaptor.

154 x 420

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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